A transvascular interventional catheter expansion system

Abstract

This application relates to the technical field of medical devices, and particularly to a transvascular interventional catheter expansion system, which is mainly used to deal with problems such as atherosclerotic plaques and thrombus to restore vascular patency. The system includes a variable-diameter guide wire, an inner tube, and a handle. The variable-diameter guide wire can adjust its diameter according to different blood density types to control the buoyancy of the guide wire in the blood, so that the guide wire floats in the blood, and its outer surface is coated with an elastic hydrophilic layer to reduce the friction with the blood vessel wall. The front end of the inner tube is provided with an inflatable balloon, and a contact electrode is arranged outside the balloon. Through the volume change of the balloon, the contact electrode can be made to fit the lesion area, and the calcified plaque can be removed by the thermal effect of the contact electrode. The handle is fixed with an outer tube, an operation channel is arranged in the middle of the outer tube, and a toggle mechanism is arranged on the handle. This application can efficiently remove calcified plaques while reducing the damage to the inner wall of the blood vessel, improving the safety of the operation, and reducing the risk of complications.

Description

Technical Field

[0001] This application relates to the technical field of medical devices, and particularly to a transvascular interventional catheter expansion system. Background Art

[0002] Vascular interventional therapy is a common medical procedure mainly used to deal with problems such as atherosclerotic plaques and thrombi to restore blood vessel patency. In recent years, with the progress of medical technology, vascular interventional devices and techniques have developed rapidly, significantly improving the success rate of surgeries and the quality of life of patients. Especially for the treatment of calcified plaques, traditional treatment methods can no longer meet the clinical needs, and new technologies and devices are emerging continuously, aiming to improve the treatment effect while reducing the occurrence of complications.

[0003] In existing vascular interventional techniques, common means include mechanical thrombectomy, catheter thrombectomy, etc. Mechanical thrombectomy mainly removes thrombi or plaques in blood vessels through physical methods, such as using a rotating blade to cut plaques or removing thrombi by negative pressure aspiration; catheter thrombectomy is to enter the interior of blood vessels through a special catheter and use the devices on the catheter to capture and remove thrombi; in addition, there are also some auxiliary tools, such as a soft and expandable polymer fiber design, which can better fit the blood vessel wall and provide mechanical support, thereby increasing the success rate of catheter aspiration thrombectomy.

[0004] Although the above-mentioned techniques have improved the effect of vascular intervention to a certain extent, there are still some deficiencies. Especially when dealing with calcified plaques, traditional guide wires have a large moving resistance in blood vessels, are not easy to control the movement, prolong the operation time, affect the operation efficiency, and traditional methods often have difficulty in effectively removing hardened calcified tissues and are prone to damage the inner wall of blood vessels. Therefore, how to efficiently and safely deal with calcified plaques has become an urgent technical problem to be solved currently. Summary of the Invention

[0005] To overcome the deficiencies of the above-mentioned prior art, this application provides a transvascular interventional catheter expansion system, which can not only adjust the buoyancy of the guide wire in the blood vessel according to the blood density of different individuals to make it float in the blood vessel, so as to reduce the friction with the blood vessel, facilitate the control of the movement of the guide wire in the blood vessel, and improve the movement efficiency; it can also adjust the diameter of the guide wire for surgeries in different parts to improve the applicability of the guide wire; it can also remove the calcified tissues of the blood vessels in the lesion area through the heat efficiency generated by the contact electrode, and can efficiently and safely deal with calcified plaques.

[0006] This application is realized through the following technical solutions:

[0007] A transvascular interventional catheter expansion system includes:

[0008] A variable diameter guide wire, the outer surface of which is covered with an elastic hydrophilic layer;

[0009] An inner tube, wherein a guide channel for a variable-diameter guide wire to pass through is provided in the middle of the inner tube along the length direction, and a balloon is provided at the front end of the inner tube, and a contact electrode is provided on the balloon;

[0010] A handle is provided with an outer tube fixed on the handle, an operation channel for the inner tube to pass through is provided in the middle of the outer tube along the length direction, and a toggle mechanism for moving the balloon out from the front end of the outer tube is provided on the handle.

[0011] By adopting the above technical solution, the variable diameter guide wire can change its own diameter as needed, thereby changing its own buoyancy in the blood, so that the guide wire can be suspended in the blood, reducing the contact between the guide wire and the blood vessel wall, reducing friction, facilitating the movement of the guide wire, and improving the efficiency of the operation; and the diameter of the guide wire can also be actively adjusted to meet the surgical needs of different parts; the elastic hydrophilic layer improves the lubricity of the variable diameter guide wire in the blood, reduces friction, and reduces the risk of damage to the blood vessel wall; the balloon at the front end of the inner tube and the contact electrode thereon can be deployed at a specific position to achieve local expansion, better fit the calcified plaque, and use the thermal effect of the contact electrode to stimulate the fibers in the calcified area to contract tightly, expand the uniform space in the calcified area, create conditions for the placement of the stent, and at the same time prevent the small thrombus that may be caused by the calcified tissue from escaping to the distal end, reduce the distal small blood vessel embolism, and help to better deal with vascular stenosis and calcified plaques; the design of the handle is convenient for doctors to operate, and the toggle mechanism allows the balloon to be moved out from the front end of the outer tube, which is convenient for adjusting and controlling the position of the catheter, and improving the efficiency and success rate of the operation.

[0012] Optionally, the elastic hydrophilic layer is made of polyurethane; the outer tube is made of polyurethane or the outer surface of the outer tube is coated with a polyurethane layer.

[0013] By adopting the above technical solutions, the polyurethane has good biocompatibility, will not cause obvious immune reactions and allergic reactions, is non-toxic and non-irritating to human tissues and blood components; and the polyurethane has good flexibility and resilience, and can pass smoothly through the complex anatomical structures of the human body without causing damage to tissues. Therefore, the material of the elastic hydrophilic layer is selected as polyurethane, which improves the lubricity and biocompatibility of the variable-diameter guide wire in the blood vessel, reduces the frictional resistance during the insertion process, and reduces the risk of damage to the blood vessel wall; the outer tube also uses a polyurethane material or is coated with a polyurethane layer, which further enhances the flexibility and durability of the system, ensures the stability and safety during the operation process, and the polyurethane has a high tensile and fracture resistance load, as well as a high ability to withstand the internal pressure stress of the tube lumen, and is more reliable during use. It should be noted that the polyurethane will enhance its flexibility at the specific temperature and humidity of human blood, further reducing the risk of damage to the blood vessel wall.

[0014] Optionally, a cavity is provided inside the variable-diameter guide wire along the length direction, and a diameter-changing mechanism is provided in the cavity. The diameter-changing mechanism is used to drive the volume of the cavity to change, so as to change the buoyancy of the variable-diameter guide wire in the blood.

[0015] By adopting the above technical solutions, a cavity is provided inside the variable-diameter guide wire along the length direction, and a diameter-changing mechanism is provided in the cavity. This mechanism can drive the volume of the cavity to change, thereby adjusting the buoyancy of the variable-diameter guide wire in the blood. This design can adjust the buoyancy of the variable-diameter guide wire in blood with different densities for different individuals, enabling the variable-diameter guide wire to better adapt to the complex environment in the blood vessel and improving the flexibility and accuracy of catheter operation; it should be noted that for vascular surgeries in different parts, in order to adapt to the inner diameter of the blood vessel, avoid blood vessel damage, and ensure the supportability and passing ability of the guide wire, guide wires of different diameters are often required. The variable-diameter guide wire in this technical solution can be adjusted according to needs, enhancing its applicability during application.

[0016] Optionally, the variable-diameter guide wire includes a flexible metal wire skeleton, and the elastic hydrophilic layer is coated on the flexible metal wire skeleton; the flexible metal wire skeleton is composed of a plurality of metal wires arranged in a circular array, and a plurality of abutting bodies are evenly distributed on the metal wires along the length direction, and the front outer surface of the abutting body has an inclined surface structure.

[0017] By adopting the above technical solution, the flexible metal wire framework enhances the flexibility and support of the variable-diameter guide wire, enabling it to smoothly advance in curved and narrow blood vessels and reducing the risk of damage to the blood vessel wall. The elastic hydrophilic layer is coated on the flexible metal wire framework, which not only improves the lubrication performance of the variable-diameter guide wire but also reduces the frictional resistance in the blood, further enhancing the safety and effectiveness of the operation. Specifically, the flexible metal wire framework is composed of several metal wires arranged in a circular array. Along the length direction of the metal wire, several abutting bodies are evenly distributed, and the outer surface of the front section of the abutting body has an inclined surface structure. This design enables the variable-diameter guide wire to better maintain stability and orientation in the blood, improving the operation accuracy and reliability of the catheter in a complex blood vessel environment. At the same time, a passing gap can be formed between adjacent abutting bodies, facilitating the penetration of the pressure sensor wire.

[0018] Optionally, the variable-diameter mechanism is a wire drawing arranged in the cavity. Along the length direction of the wire drawing, several expanding bodies are evenly distributed. The outer surface of the rear section of the expanding body has a conical surface structure adapted to the inclined surface structure of the abutting body. When the conical surface structure moves axially backward, it contacts the inclined surface structure of the abutting body and drives the abutting body to move outward.

[0019] By adopting the above technical solution, the variable-diameter mechanism can achieve precise position adjustment in the cavity of the variable-diameter guide wire without affecting the optical fiber. When the expanding body on the wire drawing moves axially backward and contacts the inclined surface structure of the abutting body, it can effectively drive the abutting body to move outward, thereby changing the buoyancy of the variable-diameter guide wire in the blood. This design not only improves the controllability of the variable-diameter guide wire but also enhances its operation flexibility and stability in a complex blood vessel environment, helping to reach the target position more accurately, reducing the frictional damage to the blood vessel wall, and improving the safety and success rate of the operation.

[0020] Optionally, the abutting body has an elliptical structure, and the expanding body has a spherical structure.

[0021] By adopting the above technical solution, the design with the abutting body having an elliptical structure and the expanding body having a spherical structure can more effectively drive the abutting body to expand outward when the wire drawing moves, thereby realizing precise control of the buoyancy of the variable-diameter guide wire. This design not only improves the stability of the variable-diameter guide wire in the blood vessel but also enhances its controllability and adaptability in a complex blood vessel environment. Among them, the abutting body has an elliptical structure, half of which is embedded in the elastic hydrophilic layer and half is exposed in the cavity, which can not only increase the contact area between the metal wire and the elastic hydrophilic layer and improve the connection reliability between the metal wire and the elastic hydrophilic layer but also provide a smooth inclined surface structure in the cavity. Moreover, compared with the spherical structure, the elliptical structure also elongates the axial width of the inclined surface structure, reducing the curvature of the cavity volume change and enabling fine control during the movement of the expanding body.

[0022] Optionally, the tail end of the flexible metal wire skeleton is fixed on the annular positioning sleeve. The inner wall of the annular positioning sleeve is provided with a positioning groove adapted to the metal wire, and an adjusting sleeve capable of axial movement is arranged on the annular positioning sleeve; the tail end of the wire drawing is fixed on the adjusting sleeve, and the wire drawing is driven to move in the cavity by controlling the displacement of the adjusting sleeve on the annular positioning sleeve.

[0023] By adopting the above technical solution, the tail end of the flexible metal wire skeleton is fixed on the annular positioning sleeve, ensuring the stability and reliability of the flexible metal wire skeleton; the positioning groove on the inner wall of the annular positioning sleeve is adapted to the metal wire, further enhancing the structural stability; the adjusting sleeve can axially move on the annular positioning sleeve, and the wire drawing is driven to move in the cavity by controlling the displacement of the adjusting sleeve, realizing the effective regulation of the buoyancy of the variable-diameter guide wire. This design structure is simple, not only improving the operation accuracy and response speed of the system, but also enhancing the reliability and flexibility of the whole system.

[0024] Optionally, the adjusting sleeve is threadedly connected to the annular positioning sleeve, and an end plate is arranged at the end of the adjusting sleeve. A connecting head is rotatably connected to the middle of the end plate. The wire drawing is fixed on the connecting head, and a wire hole for the connection wire of the pressure sensor to penetrate is arranged on the connecting head.

[0025] By adopting the above technical solution, the adjusting sleeve is threadedly connected to the annular positioning sleeve, and precise axial displacement control can be achieved by rotating the adjusting sleeve, so as to accurately adjust the position of the wire drawing in the cavity. The design of rotatably connecting the connecting head to the middle of the end plate can reduce the influence of the adjusting sleeve on the wire drawing and the wire during rotation, avoid the occurrence of wire knotting, and ensure the stability of the wire drawing during movement, avoiding position deviation caused by shaking; it should be noted that ventilation holes can be arranged on the end plate, and the ventilation holes help to balance the air pressure and ensure smooth operation.

[0026] Optionally, a fixed sleeve in a tubular structure is arranged at the front end of the variable-diameter guide wire; an exciting body is arranged on the circumference of the fixed sleeve, a pressure sensing element for sensing pressure change is arranged in the inner cavity, and a contact rod with a circular arc-shaped head is slidably connected to the front end of the fixed sleeve, and the tail of the contact rod abuts against the pressure sensing element through an elastic member.

[0027] By adopting the above technical solutions, the fixed sleeve provided at the front end of the variable-diameter guide wire provides a base for the installation of the pressure sensing element and the excitation body, ensuring the working reliability of the pressure sensing element and the excitation body; the excitation body can achieve precise control of the guidance under the support of the magnetic drive navigation technology, improving the operation accuracy; the pressure sensing element is installed in the inner cavity of the fixed sleeve, capable of monitoring the pressure change at the front end of the variable-diameter guide wire in real time, accurately judging the position of the calcified plaque, and ensuring the safety and accuracy of the operation process; the design of the contact rod with an arc-shaped head can not only effectively transmit the pressure signal, but also reduce the risk of damage to the blood vessel wall; the design of the elastic member makes the contact between the contact rod and the pressure sensing element more sensitive and reliable, further improving the response speed and measurement accuracy of the system; among them, the pressure sensing element is a fiber optic pressure sensing element, and the pressure sensing element has anti-magnetic ability and can ensure the measurement accuracy in a magnetic field.

[0028] Optionally, an air duct for guiding air and a wire channel for the electrode wire to penetrate are provided in the middle of the inner tube along the length direction; an air vent for communicating the air duct with the inner cavity of the balloon is provided on the inner tube; a fixing ring is provided on the inner tube, and a plurality of elastic pieces arranged in a spiral structure are provided on the fixing ring, and the elastic pieces cover the outside of the balloon; the electrode wire extends out of the inner tube from a through hole opened on the wire channel and is arranged in a spiral structure on the elastic pieces; the contact electrodes are evenly distributed on the elastic pieces and are connected to the electrode wire.

[0029] By adopting the above technical solutions, the air duct and the wire channel provided in the inner tube ensure the effective transmission of gas and the electrode wire, improving the reliability and operability of the system. The design of the air vent enables the gas to smoothly enter the inner cavity of the balloon, realizing the rapid inflation and deflation of the balloon, enhancing the maneuverability and flexibility of the device in the blood vessel. The elastic pieces arranged in a spiral structure on the fixing ring not only increase the stability of the balloon, but also effectively disperse the pressure of the electrode wire, reducing the risk of damage to the blood vessel wall. The electrode wire is arranged in a spiral structure on the elastic pieces, so that the contact electrodes are evenly distributed on the surface of the balloon, ensuring the uniform distribution of the radio frequency energy, and improving the treatment effect and safety.

[0030] In summary, the present application includes at least one of the following beneficial technical effects:

[0031] The pressure sensor and the elastic hydrophilic layer provided at the front end of the variable-diameter guide wire of the present application make the movement of the guide wire in the blood vessel smoother, reducing the friction and damage to the inner wall of the blood vessel, and improving the safety of the operation and the convenience of the operation;

[0032] The balloon at the front end of the inner tube of the present application and the electrode pieces thereon can generate a local thermal effect under the action of bipolar radio frequency, effectively stimulating the fibrous tight contraction of the calcified area, expanding the space of the calcified area, creating favorable conditions for the subsequent stent placement, and reducing the risk of distal small blood vessel embolism caused by the shedding of calcified tissue;

[0033] The cavity provided inside the variable-diameter guide wire of the present application and the variable-diameter mechanism provided in the cavity can drive the volume of the cavity to change, thereby adjusting the buoyancy of the variable-diameter guide wire in the blood, enabling the variable-diameter guide wire to better adapt to the complex environment inside the blood vessel and improving the flexibility and accuracy of catheter operation;

[0034] The present application can adjust the diameter for vascular surgeries at different sites to adapt to different blood vessel inner diameters, avoid blood vessel damage, ensure the supportability and passing ability of the guide wire, and enhance its applicability during the application process. Description of the Drawings

[0035] Figure 1 is the overall structural schematic diagram of the transvascular interventional catheter expansion system described in Embodiment 1;

[0036] Figure 2 is the internal structural schematic diagram of the transvascular interventional catheter expansion system described in Embodiment 1;

[0037] Figure 3 is the structural schematic diagram of the outer tube described in Embodiment 1;

[0038] Figure 4 is the structural schematic diagram of the inner tube described in Embodiment 1;

[0039] Figure 5 is the structural schematic diagram of the balloon described in Embodiment 1;

[0040] Figure 6 is the partial structural schematic diagram of the inner tube described in Embodiment 1;

[0041] Figure 7 is the structural schematic diagram of the variable-diameter guide wire described in Embodiment 1;

[0042] Figure 8 is the combined structural schematic diagram of the annular positioning sleeve and the adjusting sleeve described in Embodiment 1;

[0043] Figure 9 is the enlarged partial structural schematic diagram of the adjusting sleeve described in Embodiment 1;

[0044] Figure 10 is the layout structural schematic diagram of the positioning groove described in Embodiment 1;

[0045] Figure 11 is the structural schematic diagram of the head of the variable-diameter guide wire described in Embodiment 1;

[0046] Figure 12 is the structural schematic diagram of the fixing sleeve described in Embodiment 1;

[0047] Figure 13is a schematic diagram of the arrangement structure of the metal wire and the fixing sleeve described in the first embodiment;

[0048] Figure 14 It is a schematic structural diagram of the variable diameter guide wire head described in Example 2.

[0049] In the figure: 1, variable diameter guide wire; 11, elastic hydrophilic layer; 12, metal wire; 121, abutment body; 13, wire drawing; 131, expansion body; 14, annular positioning sleeve; 141, positioning groove; 15, adjustment sleeve; 151, end plate; 152, air vent; 153, mark foot; 16, connector; 161, positioning shoulder; 162, slot; 163, wire hole; 17, fixing sleeve; 171, touch rod ; 172, elastic part; 18, pressure sensing element; 19, exciter; 2, inner tube; 21, guide channel; 22, airway; 221, air guide hole; 23, wire channel; 231, through hole; 24, balloon; 241, spacer; 25, fixing ring; 26, elastic sheet; 27, electrode wire; 28, contact electrode; 3, outer tube; 31, operation channel; 4, handle; 5, dial; 6, display screen. DETAILED DESCRIPTION

[0050] The following will clearly and completely describe the technical solutions of the embodiments of the present application in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Based on the embodiments of the present application, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present application. Embodiment 1

[0051] Reference Figure 1 The embodiment of the present application discloses a transvascular interventional catheter expansion system, comprising a variable-diameter guide wire 1, an inner tube 2 and a handle 4, wherein a guide channel 21 for the variable-diameter guide wire 1 to pass through is provided in the middle portion of the inner tube 2 along the length direction, and a balloon 24 is provided at the front end of the inner sleeve, and a contact electrode is provided on the balloon 24; an outer tube 3 is fixed on the handle 4, an operation channel 31 for the inner tube 2 to pass through is provided in the middle portion of the outer tube 3 along the length direction, and a toggle mechanism for moving the balloon 24 out from the front end of the outer tube 3 is provided on the handle 4.

[0052] Specifically, refer to Figures 2 to 3An outer tube 3 is fixed on the handle 4, and an operating channel 31 for the inner tube 2 to pass through is provided in the middle of the outer tube 3 along the length direction, and a toggle mechanism for moving the balloon 24 out from the front end of the outer tube 3 is provided on the handle 4. The design of the handle 4 is simple and practical, which is convenient for doctors to operate. At the same time, the addition of the toggle mechanism makes the deployment and retraction of the balloon 24 more convenient, and improves the flexibility and controllability of the operation. Among them, the outer tube 3 is made of polyurethane material or the outer surface of the outer tube 3 is covered with a polyurethane layer to enhance the flexibility and durability of the system, ensure the stability and safety during operation, and has high tensile and fracture load resistance, as well as high intraluminal pressure stress tolerance, which is more reliable during use. It should be pointed out that polyurethane will improve flexibility under the specific temperature and humidity of human blood, further reducing the risk of damage to the blood vessel wall.

[0053] Reference Figures 2 to 3 In order to further facilitate the medical staff to perform visual operations, a display screen 6 for displaying the air pressure and temperature inside the balloon 24 can be provided on the handle 4; and the toggle mechanism is a dial wheel 5 arranged at the tail end of the inner tube 2, and a sliding hole adapted for the dial wheel 5 is provided on the handle 4. When the outer tube 3 reaches the target position, the dial wheel 5 can be pushed to move the balloon 24 out from the front end of the outer tube 3.

[0054] Reference Figures 4 to 6 The middle part of the inner tube 2 is also provided with an airway 22 for air conduction and a wire channel 23 for the electrode wire 27 to pass through along the length direction. The inner tube 2 is provided with an air guide hole 221 for connecting the airway 22 with the inner cavity of the balloon 24, and a fixing ring 25 is sleeved on the inner tube 2. The fixing ring 25 is provided with a plurality of elastic sheets 26 arranged in a spiral structure. The elastic sheets 26 are coated on the outside of the balloon 24, and the electrode wire 27 passes through the through hole 231 opened on the wire channel 23 and is arranged on the elastic sheet 26 in a spiral structure. In order to facilitate the installation of the electrode wire 27 and meet the sealing requirements, the fixing ring 25 can also be provided with a through hole for the electrode wire 27 to pass through. After the electrode wire 27 passes through, a sealing method can be adopted. The sealing material is used for sealing, and the electrode wire 27 arranged on the elastic sheet 26 can be covered by an insulating coating; the contact electrode 28 adopts a bipolar electrode, which is evenly distributed on the elastic sheet 26 in a spiral structure and is connected to the electrode wire 27, and can generate a thermal effect through high-frequency current; such a design enables the electrode sheet to be evenly distributed on the balloon 24, thereby improving the efficiency and stability of energy transfer, and at the same time the balloon 24 also provides the contact electrode 28 with expansion ability and fit; in order to further ensure the position of the elastic sheet 26 on the balloon 24, a partition bar 241 can be provided on the balloon 24; it should be pointed out that an air pressure sensor and a temperature sensor can be provided in the airway 22, and their sensing values can be displayed on the display screen 6.

[0055] Specifically, refer to Figure 7, the variable-diameter guide wire 1 includes a flexible metal wire skeleton, and an elastic hydrophilic layer 11 is coated on the flexible metal wire skeleton. The advantage of this design is that while ensuring the bending flexibility of the variable-diameter guide wire 1, it also improves the supportability of the variable-diameter guide wire 1, preventing it from undergoing tensile deformation in the axial direction, thereby ensuring that it can more easily pass through blood vessels and providing a structural basis for the adjustment of the variable-diameter mechanism. Similarly, the material of the elastic hydrophilic layer 11 coated on the outer surface of the variable-diameter guide wire 1 is polyurethane, and a cavity is provided inside the variable-diameter guide wire 1 along the length direction. A variable-diameter mechanism is provided in the cavity, and the variable-diameter mechanism is used to drive the volume of the cavity to change, thereby changing the buoyancy of the variable-diameter guide wire 1 in the blood. This enables the variable-diameter guide wire 1 to adjust its position in the blood vessel according to actual needs and more flexibly respond to complex blood vessel environments.

[0056] More specifically, referring to Figure 7 , the flexible metal wire skeleton is composed of several metal wires 12 arranged in an annular array. Along the length direction of each metal wire 12, several abutting bodies 121 are evenly distributed. The outer surface of the front section of the abutting body 121 has an inclined surface structure, and the inclined surface structure is exposed in the cavity. The advantage of this design is that it increases the flexibility and bending resistance of the variable-diameter guide wire 1, making it easier to pass through blood vessels. The variable-diameter mechanism is a wire drawing 13 arranged in the cavity. Along the length direction of the wire drawing 13, several expansion bodies 131 are evenly distributed. The outer surface of the rear section of the expansion body 131 has a conical surface structure adapted to the inclined surface structure of the abutting body 121. When the conical surface structure moves axially backward, it will contact the inclined surface structure of the abutting body 121 and drive the abutting body 121 to move outward, thereby changing the volume of the cavity and realizing the adjustment of buoyancy. The abutting body 121 has an elliptical structure, and the expansion body 131 has a spherical structure. This design not only ensures sufficient support force but also does not cause excessive pressure on the blood vessel wall, reducing the risk of injury. Among them, in general surgeries, the metal wire 12 can be made of stainless steel or nitinol, with a diameter of 0.03 mm to 0.1 mm; the major axis length of the abutting body 121 is 0.5 mm to 1 mm, and the minor axis length is 0.1 mm to 0.3 mm; the wire drawing 13 can be made of stainless steel or nitinol, with a diameter of 0.05 mm to 0.1 mm; the diameter of the expansion body 131 is 0.1 mm to 0.3 mm.

[0057] Referring to Figures 8 to 10, the tail end of the flexible metal wire skeleton is fixed on the annular positioning sleeve 14. A positioning groove 141 adapted to the metal wire 12 is provided on the inner wall of the annular positioning sleeve 14, and an adjusting sleeve 15 that can move axially is provided on the annular positioning sleeve 14; the tail end of the wire drawing 13 is fixed on the adjusting sleeve 15, and by controlling the displacement of the adjusting sleeve 15 on the annular positioning sleeve 14, the wire drawing 13 is driven to move in the cavity; the adjusting sleeve 15 is threadedly connected to the annular positioning sleeve 14, and an end plate 151 is provided at the end of the adjusting sleeve 15. A connecting head 16 is rotatably connected to the middle of the end plate 151. The wire drawing 13 is fixed on the connecting head 16, and a wire passing hole 163 for the wire to pass through is provided on the connecting head 16. An air vent hole 152 is provided on the end plate 151 to balance the air pressure and ensure the smoothness of the operation; by rotating the adjusting sleeve 15, the adjusting sleeve 15 can be driven to move on the annular positioning sleeve 14, thereby changing the position of the wire drawing 13 in the cavity. In order to make the operation visual, scale lines can be set on the annular positioning sleeve 14, and an extended scale foot 153 can be provided at the end of the adjusting sleeve 15; the above series of designs make the adjustment of the variable-diameter guide wire 1 more accurate and the operation more convenient.

[0058] Reference Figures 11 to 13 , a fixing sleeve 17 in a tubular structure is provided at the front end of the variable-diameter guide wire 1; a pressure sensing element 18 for sensing pressure changes is fixed in the inner cavity of the fixing sleeve 17. Specifically, the pressure sensing element 18 can adopt a semiconductor piezoelectric sheet; a contact rod 171 with a circular arc-shaped head is slidably connected to the fixing sleeve 17, and the tail of the contact rod 171 abuts against the pressure sensing element 18 through an elastic member 172. Among them, the fixing sleeve 17 provided at the front end of the variable-diameter guide wire 1 provides a base for the installation of the pressure sensor and ensures the reliability of the operation of the pressure sensing element 18; the design of the contact rod 171 with a circular arc-shaped head can not only effectively transmit the pressure signal but also reduce the risk of damage to the blood vessel wall; the design of the elastic member 172 makes the contact between the contact rod 171 and the pressure sensor more sensitive and reliable, further improving the response speed and measurement accuracy of the system.

[0059] The implementation principle of this embodiment is as follows: the pressure sensing element 18 is installed in the inner cavity of the fixing sleeve 17, and can monitor the pressure change of the front end of the variable diameter guide wire 1 during the movement in real time. When the sensed pressure value exceeds the preset threshold value in the system control unit, the path can be adjusted or the position of the calcified plaque can be accurately determined to ensure the safety and accuracy of the operation process; the use of the elastic hydrophilic layer 11 improves the lubricity of the variable diameter guide wire 1 in the blood, reduces friction, and reduces the risk of damage to the blood vessel wall; the balloon 24 at the front end of the inner tube 2 and the contact electrode 28 thereon can be deployed at a specific position to achieve local expansion and better fit the calcified plaque. The thermal effect of the contact electrode 28 is used to stimulate the fibers in the calcified area to contract tightly, expand the uniform space in the calcified area, create conditions for the placement of the stent, and prevent the small thrombus that may be caused by the calcified tissue from spreading to the distant The handle 4 is designed to facilitate the doctor's operation, and the toggle mechanism allows the balloon 24 to be moved out from the front end of the outer tube 3, which is convenient for adjusting and controlling the position of the catheter, thereby improving the efficiency and success rate of the operation. The diameter and buoyancy of the guide wire can be adjusted by the variable diameter mechanism, thereby adjusting the buoyancy of the variable diameter guide wire 1 in blood of different densities, so that the variable diameter guide wire 1 can better adapt to the complex environment in the blood vessel, and improve the flexibility and accuracy of catheter operation. In another usage scenario, for vascular surgery at different parts, in order to adapt to the inner diameter of the blood vessel, avoid vascular damage, and ensure the support and passing ability of the guide wire, guide wires of different diameters are often required. The guide wires with variable diameters in the present technical solution can be adjusted as needed, which enhances its applicability in the application process. Embodiment 2

[0060] Reference Figure 14 The difference between this embodiment and the first embodiment is that a mounting groove is provided on the circumference of the fixing sleeve 17, and an excitation body 19 is fixed in the mounting groove, which may also be in the form of an induction coil; the pressure sensor is an optical fiber pressure sensor, and the pressure sensing element 18 may adopt an optical fiber Bragg grating or an FP cavity. As an existing technology, the optical fiber Bragg grating is a special optical fiber structure that can reflect light of a specific wavelength. When external pressure acts on the optical fiber Bragg grating, it will cause a change in the grating period, thereby causing a shift in the wavelength of the reflected light. By detecting the change in the wavelength of the reflected light, the pressure can be measured; and the FP cavity is an optical fiber structure based on the principle of multi-beam interference of light. When external pressure acts on the FP cavity, it will cause a change in the cavity length, thereby causing the movement of the interference fringes. By detecting the change in the interference fringes, the pressure can be measured.

[0061] The implementation principle of this embodiment is as follows: With the support of magnetic drive navigation technology, the excitation body 19 can achieve precise control of guidance and improve operation accuracy. The pressure sensing element 18 is a fiber optic pressure sensing element 18, which can have strong anti-magnetic ability and ensure the accuracy of measurement even in a magnetic field.

[0062] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present application, and are not intended to limit them. Although the present application has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that they can still modify the technical solutions described in the foregoing embodiments, or perform equivalent replacements on some or all of the technical features; and these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the technical solutions of the embodiments of the present application.

Claims

1. A transvascular interventional catheter expansion system, characterized in that, include: A variable diameter guide wire (1), the outer surface of the variable diameter guide wire (1) being coated with an elastic hydrophilic layer (11); the variable diameter guide wire (1) is provided with a cavity arranged along the length direction, the cavity being provided with a variable diameter mechanism, the variable diameter mechanism being used to drive the cavity volume to change, so as to change the buoyancy of the variable diameter guide wire (1) in the blood; An inner tube (2), wherein a guide channel (21) for the variable-diameter guide wire (1) to pass through is provided in the middle of the inner tube (2) along the length direction, and a balloon (24) is provided at the front end of the inner tube (2), and a contact electrode (28) is provided on the balloon (24); A handle (4) is fixed to an outer tube (3), a middle portion of the outer tube (3) is provided with an operation channel (31) along the length direction for the inner tube (2) to pass through, and a toggle mechanism for moving the balloon (24) out from the front end of the outer tube (3) is provided on the handle (4).

2. The transvascular interventional catheter expansion system according to claim 1, wherein, The material of the elastic hydrophilic layer (11) is polyurethane; the outer tube (3) is made of polyurethane material or the outer surface of the outer tube (3) is coated with a polyurethane layer.

3. The transvascular interventional catheter expansion system according to claim 1, wherein The variable diameter guide wire (1) comprises a flexible metal wire skeleton, and the elastic hydrophilic layer (11) is coated on the flexible metal wire skeleton; the flexible metal wire skeleton is composed of a plurality of metal wires (12) arranged in a ring array, and a plurality of abutment bodies (121) are evenly distributed on the metal wires (12) along the length direction, and the front section outer surface of the abutment body (121) has a slope structure.

4. The transvascular interventional catheter expansion system according to claim 3, wherein, The diameter-changing mechanism is a wire drawing (13) arranged in the cavity, and a plurality of expansion bodies (131) are evenly distributed on the wire drawing (13) along the length direction; the rear outer surface of the expansion body (131) has a conical surface structure that matches the inclined surface structure of the abutment body (121); when the conical surface structure moves axially toward the rear section, it contacts the inclined surface structure of the abutment body (121) and drives the abutment body (121) to move outward.

5. The transvascular interventional catheter expansion system according to claim 4, wherein, The abutment body (121) has an elliptical structure, and the expansion body (131) has a spherical structure.

6. The transvascular interventional catheter expansion system according to claim 4, wherein The tail end of the flexible metal wire skeleton is fixed on an annular positioning sleeve (14); a positioning groove (141) adapted to fit the metal wire (12) is provided on the inner wall of the annular positioning sleeve (14); and an adjustment sleeve (15) movable in the axial direction is provided on the annular positioning sleeve (14); the tail end of the wire drawing (13) is fixed on the adjustment sleeve (15); and the wire drawing (13) is driven to move in the cavity by controlling the displacement of the adjustment sleeve (15) in the annular positioning sleeve (14).

7. The transvascular interventional catheter expansion system according to claim 6, wherein, The adjusting sleeve (15) is threadedly connected to the annular positioning sleeve (14), and an end plate (151) is provided at the end of the adjusting sleeve (15). A connecting head (16) is rotatably connected to the middle of the end plate (151). The wire drawing (13) is fixed to the connecting head (16), and a wire hole (163) for the pressure sensor connecting wire to pass through is provided on the connecting head (16).

8. The transvascular interventional catheter expansion system according to claim 2, wherein The front end of the variable-diameter guide wire (1) is provided with a fixed sleeve (17) in a tubular structure; an exciting body (19) is arranged circumferentially on the fixed sleeve (17), a pressure sensing element (18) for sensing pressure changes is arranged in the inner cavity, and a contact rod (171) with an arc-shaped head is slidably connected to the front end of the fixed sleeve (17), and the tail of the contact rod (171) abuts against the pressure sensing element (18) through an elastic member (172).

9. The transvascular interventional catheter expansion system according to claim 1, wherein An air duct (22) for guiding air and a wire channel (23) for the electrode wire (27) to pass through are arranged along the length direction in the middle of the inner tube (2); an air guide hole (221) for communicating the air duct (22) with the inner cavity of the balloon (24) is arranged on the inner tube (2); a fixing ring (25) is arranged on the inner tube (2), and a plurality of elastic pieces (26) arranged in a spiral structure are arranged on the fixing ring (25), and the elastic pieces (26) cover the outside of the balloon (24); the electrode wire (27) extends out of the inner tube (2) from a through hole (231) opened on the wire channel (23) and is arranged in a spiral structure on the elastic pieces (26); the contact electrodes (28) are uniformly arranged on the elastic pieces (26) and are communicated with the electrode wire (27).

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